BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIPOLLAR STOP X

    MDR report key: 15113639 · Received July 26, 2022

    Report

    Report Number
    MW5111144
    Event Type
    Injury
    Date Received
    July 26, 2022
    Report Date
    July 25, 2022
    Manufacturer
    POLLOGEN LTD.
    Product Code
    PAY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DC, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I PURCHASED TRIPOLLARBEAUTY'S TRIPOLLAR STOP X, A TOOL THAT ALLEGEDLY USES THIRD GENERATION RADIO FREQUENCY TO BOOST ELASTIN AND COLLAGEN PRODUCTION, TIGHTEN THE SKIN AND DIMINISH FINE LINES BY ENCOURAGING THE MUSCLES TO TIGHTEN, CREATING A MORE LIFTED APPEARANCE. THE COMPANY STATES THAT 80% OF PARTICIPANTS SHOWED AN IMPROVEMENT IN THE APPEARANCE OF FINE LINES AND WRINKLES. TRIPOLLAR ALSO STATED THAT THE PRODUCT WAS SAFE TO USE IF YOU HAD MELASMA AND WOULD NOT WORSEN THE CONDITION. AFTER USING THE PRODUCT, I NOTICED A DARKENING IN MY SKIN WHICH MY DERMATOLOGIST STATED WAS A WORSENING ON THE MELASMA IN MY SKIN DUE TO THE HEAT FROM THE TRIPOLLAR DEVICE. I ALSO EXPERIENCED A "SHOCK" LIKE OCCURRENCE WHICH WAS NOT ONLY PAINFUL BUT CAUSED SEVERE MIGRAINES SHORTLY AFTER. WHEN I CONTACTED THE COMPANY, THEY DENIED MY RETURN AND REFUSED TO ACCEPT THE PRODUCT BACK IN ORDER TO RESEARCH THE ISSUE FURTHER. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2425457 TRIPOLLAR STOP X OVER-THE-COUNTER RADIOFREQUENCY COAGULATION DEVICE FOR WRINKLE REDUCTION PAY POLLOGEN LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Other MULTIVITAMIN